Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1616-2026 — Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

U.S. FDA — Device Enforcement · United States · 2026-03-02 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1616-2026
Date of alert
2026-03-02
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Philips Respironics, Inc.
Product category
device
Product type
Devices
Reported risk: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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